Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012/06163-6 | Other Grant/Funding Number | FAPESP - SAO PAULO RESEARCH FOUNDATION |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate control in patients with decompensated heart failure (DHF).
Sympathetic hyperactivity and consequent increase in heart rate (HR) are physiological responses to low cardiac output in patients with decompensated heart failure (DHF). However, elevated HR may become inappropriate in these patients, increasing myocardial oxygen demand and decreasing diastolic filling time and might lead to hemodynamic deterioration, ventricular dysfunction (tachycardiomyopathy) and clinical deterioration.
Studies show the elevated HR is a predictor of poor prognosis in DHF. Subanalyses of large clinical trials using beta blockers (BBs) demonstrate the adequate control of HR correlates with a better outcome in patients with stable chronic heart failure (HF). However, use of BBs in patients with DHF is limited due to negative inotropic and hypotensive effects of these drugs.
As alternative to BBs, ivabradine has shown to increase survival of patients with chronic stable systolic HF. Compared to BBs, ivabradine has the advantage of "pure" negative chronotropic effect, no effect on myocardial contractility or peripheral vascular resistance. Despite the inhibition of I (f) has been validated as a therapeutic option in patients with stable HF, there are no studies available on this strategy in patients with DHF.
We hypothesized that HR control by ivabradine might improve clinical, hemodynamic and neurohormonal parameters in patients with DHF. The aim of this study was to evaluate the efficacy of HR control with ivabradine in patients with DHF.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ivabradine | Experimental | I(f) inhibitor, heart rate controller |
|
| placebo | Placebo Comparator | placebo pill will be administered orally twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivabradine | Drug | 5 mg oral twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline heart rate | Heart rate will be assessed at morning, after 30 minutes of rest, recorded by electrocardiogram. | Baseline, day 5 after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline blood pressure | Blood pressure will be measured at morning by electronic cuff | Baseline, day 5 after intervention |
| Change from baseline ejection fraction | Ejection fraction will be measured by echocardiography using Simpson´s rule |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/Adverse Event Outcome Measure | Number of Participants with Serious and Non-Serious Adverse Events | Up to day 15 days after intervention |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco S. Alves, MD | Contact | +55 11 981431512 | marco.alves@incor.usp.br | |
| Edimar A. Bocchi, MD-PHD | Contact | +55 11 2661-5419 | edimar.bocchi@incor.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Edimar A Bocchi, MD-PHD | Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Failure Unit, Heart Institute, University of Sao Paulo Medical School | Recruiting | São Paulo | São Paulo | 05403-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27469019 | Result | Lofrano-Alves MS, Issa VS, Biselli B, Chizzola P, Ayub-Ferreira SM, Bocchi EA. Control of sinus tachycardia as an additional therapy in patients with decompensated heart failure (CONSTATHE-DHF): A randomized, double-blind, placebo-controlled trial. J Heart Lung Transplant. 2016 Oct;35(10):1260-1264. doi: 10.1016/j.healun.2016.06.005. Epub 2016 Jun 7. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | A placebo pill (identical to ivabradine) will be administered twice daily |
|
| Baseline, day 5 after intervention |
| Change from baseline stroke volume | Stroke volume will be measured by echocardiography using Doppler velocity-time integral technique. | Baseline, day 5 after intervention |
| Change from baseline creatinine | Serum creatinine will be measured | Baseline, day 5 after intervention |
| Change from baseline brain natriuretic peptide | Serum brain natriuretic peptide will be measured | Baseline, day 5 after intervention |
| Clinical | Time of survival and free of readmission | Up to 6 months |