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Spironolactone significantly improved left ventricular diastolic function and remodeling in a 1-year study of ambulatory patients who had heart failure with preserved ejection fraction, but that benefit did not translate into improvements in HF symptoms or quality of life, according to a report in the Feb. 27 issue of JAMA.
In the multicenter, double-blind Aldosterone Receptor Blockade in Diastolic HF (Aldo-DHF) clinical trial, 213 men and women aged 50 and older were randomly assigned to receive daily oral spironolactone and 209 to receive a matching placebo for 1 year. Patients on spironolactone had significantly increased LV ejection fraction, decreased LV end-diastolic diameter and LV mass index, and reduced systolic blood pressure, reported Dr. Burkert M. Pieske, professor and head of the department of cardiology at Medical University of Graz, Austria, and his associates.
The drug failed to improve HF symptoms, exercise capacity, depressive symptoms, or quality of life, compared with placebo. "Our study population may have been too young or too healthy, or the treatment period may have been too short, for observing a translation of improved diastolic function into a clinical benefit," the investigators said (JAMA 2013;309:781-91).
These results were presented at the annual meeting of the European Society of Cardiology in Munich last summer, and reported by this newspaper.
Experts reacting to the news at the meeting expressed similar misgivings.
"It was not all good news. Patients had an increase in their potassium level, and even more concerning, they had a reduction in their glomerular filtration rate, an average reduction of about 5 mL/min," commented Dr. Stefan D. Anker, professor of medicine at Charité Medical University in Berlin. In addition, the distance walked on the 6-minute walk test was "slightly decreased with spironolactone. Even though it was a small change of 15 m, it was statistically significant," he noted. On top of all this, "worsening of anemia was seen in patients," he added.
Study discussant Dr. John G.F. Cleland said that although the Aldo-DHF study adds important new information on the progression of diastolic heart failure as seen in the control group, it wasn’t really was a study of diastolic heart failure. Few of the patients were on diuretic drugs, at entry they had fairly normal levels of NT-proBNP, they had mild abnormalities detected by echocardiography, and they exhibited mild deficits in cardiopulmonary exercise testing, said Dr. Cleland, professor of cardiology at the University of Hull, Kingston-upon-Hull, England.
Aldo-DHF was supported by the German-Austrian Heart Failure Study Group and the German Competence Network of Heart Failure. Dr. Edelmann and his associates reported numerous ties to industry sources.
Spironolactone significantly improved left ventricular diastolic function and remodeling in a 1-year study of ambulatory patients who had heart failure with preserved ejection fraction, but that benefit did not translate into improvements in HF symptoms or quality of life, according to a report in the Feb. 27 issue of JAMA.
In the multicenter, double-blind Aldosterone Receptor Blockade in Diastolic HF (Aldo-DHF) clinical trial, 213 men and women aged 50 and older were randomly assigned to receive daily oral spironolactone and 209 to receive a matching placebo for 1 year. Patients on spironolactone had significantly increased LV ejection fraction, decreased LV end-diastolic diameter and LV mass index, and reduced systolic blood pressure, reported Dr. Burkert M. Pieske, professor and head of the department of cardiology at Medical University of Graz, Austria, and his associates.
The drug failed to improve HF symptoms, exercise capacity, depressive symptoms, or quality of life, compared with placebo. "Our study population may have been too young or too healthy, or the treatment period may have been too short, for observing a translation of improved diastolic function into a clinical benefit," the investigators said (JAMA 2013;309:781-91).
These results were presented at the annual meeting of the European Society of Cardiology in Munich last summer, and reported by this newspaper.
Experts reacting to the news at the meeting expressed similar misgivings.
"It was not all good news. Patients had an increase in their potassium level, and even more concerning, they had a reduction in their glomerular filtration rate, an average reduction of about 5 mL/min," commented Dr. Stefan D. Anker, professor of medicine at Charité Medical University in Berlin. In addition, the distance walked on the 6-minute walk test was "slightly decreased with spironolactone. Even though it was a small change of 15 m, it was statistically significant," he noted. On top of all this, "worsening of anemia was seen in patients," he added.
Study discussant Dr. John G.F. Cleland said that although the Aldo-DHF study adds important new information on the progression of diastolic heart failure as seen in the control group, it wasn’t really was a study of diastolic heart failure. Few of the patients were on diuretic drugs, at entry they had fairly normal levels of NT-proBNP, they had mild abnormalities detected by echocardiography, and they exhibited mild deficits in cardiopulmonary exercise testing, said Dr. Cleland, professor of cardiology at the University of Hull, Kingston-upon-Hull, England.
Aldo-DHF was supported by the German-Austrian Heart Failure Study Group and the German Competence Network of Heart Failure. Dr. Edelmann and his associates reported numerous ties to industry sources.
Spironolactone significantly improved left ventricular diastolic function and remodeling in a 1-year study of ambulatory patients who had heart failure with preserved ejection fraction, but that benefit did not translate into improvements in HF symptoms or quality of life, according to a report in the Feb. 27 issue of JAMA.
In the multicenter, double-blind Aldosterone Receptor Blockade in Diastolic HF (Aldo-DHF) clinical trial, 213 men and women aged 50 and older were randomly assigned to receive daily oral spironolactone and 209 to receive a matching placebo for 1 year. Patients on spironolactone had significantly increased LV ejection fraction, decreased LV end-diastolic diameter and LV mass index, and reduced systolic blood pressure, reported Dr. Burkert M. Pieske, professor and head of the department of cardiology at Medical University of Graz, Austria, and his associates.
The drug failed to improve HF symptoms, exercise capacity, depressive symptoms, or quality of life, compared with placebo. "Our study population may have been too young or too healthy, or the treatment period may have been too short, for observing a translation of improved diastolic function into a clinical benefit," the investigators said (JAMA 2013;309:781-91).
These results were presented at the annual meeting of the European Society of Cardiology in Munich last summer, and reported by this newspaper.
Experts reacting to the news at the meeting expressed similar misgivings.
"It was not all good news. Patients had an increase in their potassium level, and even more concerning, they had a reduction in their glomerular filtration rate, an average reduction of about 5 mL/min," commented Dr. Stefan D. Anker, professor of medicine at Charité Medical University in Berlin. In addition, the distance walked on the 6-minute walk test was "slightly decreased with spironolactone. Even though it was a small change of 15 m, it was statistically significant," he noted. On top of all this, "worsening of anemia was seen in patients," he added.
Study discussant Dr. John G.F. Cleland said that although the Aldo-DHF study adds important new information on the progression of diastolic heart failure as seen in the control group, it wasn’t really was a study of diastolic heart failure. Few of the patients were on diuretic drugs, at entry they had fairly normal levels of NT-proBNP, they had mild abnormalities detected by echocardiography, and they exhibited mild deficits in cardiopulmonary exercise testing, said Dr. Cleland, professor of cardiology at the University of Hull, Kingston-upon-Hull, England.
Aldo-DHF was supported by the German-Austrian Heart Failure Study Group and the German Competence Network of Heart Failure. Dr. Edelmann and his associates reported numerous ties to industry sources.
FROM JAMA
Major Finding: Daily spironolactone significantly increased LV ejection fraction, decreased LV end-diastolic volume and LV mass index, and reduced systolic blood pressure, but did not improve HF symptoms, exercise capacity, depressive symptoms, or quality of life.
Data Source: Aldo-DHF, a 1-year multicenter double-blind randomized controlled trial involving 422 patients aged 50 and older who had chronic HF with preserved ejection fraction.
Disclosures: Aldo-DHF was supported by the German-Austrian Heart Failure Study Group and the German Competence Network of Heart Failure. Dr. Edelmann and his associates reported numerous ties to industry sources.
