Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction

Last updated: January 30, 2024
Sponsor: Xinjiang Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Hyponatremia

Chest Pain

Treatment

Renal denervation and maintenance of heart failure medications

Sham procedure and maintenance of heart failure medications

Clinical Study ID

NCT05715697
20230126-03
  • Ages 21-80
  • All Genders

Study Summary

This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. signs or symptoms of heart failure;
  2. normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
  3. evidence of diastolic LV dysfunction.
  4. Individual should fulfill the diagnostic WHO criteria for hypertension: SBP > 140 mmHgand/or DBP > 90 mmHg, and is treated with at least 2 antihypertensive drugs. Thistreatment is expected to be maintained for at least 6 months. Using this regimen theblood pressure should be adequately controlled (< 140/90mmHg by 24 hour ambulatory BPmeasurement).
  5. Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimumof 2 weeks prior to enrollment, and which is expected to be maintained for at least 6months.

Exclusion

Exclusion Criteria:

  1. Known secondary cause of hypertension
  2. Anatomy not eligible for renal denervation
  3. Systolic heart failure (LVEF < 50%)
  4. Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2,using the MDRD calculation.
  5. Individual has any serious medical condition, which in the opinion of theinvestigator, may adversely affect the safety and/or effectiveness of the participantor the study (i.e., patients with clinically significant peripheral vascular disease,abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia,significant anaemia, or arrhythmias such as atrial fibrillation).
  6. Individual is pregnant, nursing or planning to be pregnant.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Renal denervation and maintenance of heart failure medications
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
September 01, 2026

Study Description

Heart failure is one of the most important diseases worldwide, with a 5-year mortality of up to 75% in symptomatic patients. While substantial progress has been made in the treatment of patients with reduced left ventricular ejection fraction (HFrEF), mortality for patients with heart failure and preserved ejection fraction (HFpEF) remains unchanged, despite a comparable prevalence and mortality of the disease as for heart failure with reduced ejection fraction. Heart failure with preserved ejection fraction has a high mortality, which is contrasted by a total absence of therapy options besides symptomatic diuretic treatment. This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Connect with a study center

  • The First Affiliated Hospital of Xinjiang Medical University

    Urumqi, Xinjiang 830000
    China

    Active - Recruiting

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