NCT04434664

BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF

BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in Heart Failure With Preserved Ejection Fraction (BLOCK HFpEF) Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Heart failure with preserved ejection fraction (HFpEF) is a critical public health problem. Heart failure (HF) affects over 5 million adults in the United States (US), and is a major source of morbidity, mortality, and impaired quality of life. Approximately half of individuals with HF have a preserved left ventricular (LV) ejection fraction (EF), termed HF with preserved EF (HFpEF). While there are several effective pharmacologic therapies for HF with reduced ejection fraction (HFrEF), none have been identified for HFpEF. Hypertension, which is present in approximately 80% of individuals with HFpEF, is the foremost modifiable risk factor for the development and progression of HFpEF. Despite the clinical importance of hypertension in HFpEF, there is limited information on how common antihypertensive agents, particularly calcium channel blockers (CCBs) and β-blockers, effect pathophysiologic mechanisms of HFpEF. This is a mechanistic investigation of the role of dihydropyridine CCBs compared to β-blockers (commonly used antihypertensive agents in clinical practice) in targeting key physiologic abnormalities in HFpEF.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine Besylate	The interventions will be implemented in random order in a crossover (AB-BA) design, separated by an approximately one-week washout period
DRUG	Metoprolol Succinate	The interventions will be implemented in random order in a crossover (AB-BA) design, separated by an approximately one-week washout period

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-12-03
• Completion: 2024-12-20
• First posted: 2020-06-17
• Last updated: 2026-01-30
• Results posted: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study