Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorXinjiang Medical University
About this trial
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
Qualifiers
signs or symptoms of heart failure;
normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
evidence of diastolic LV dysfunction.
Individual should fulfill the diagnostic WHO criteria for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (< 140/90mmHg by 24 hour ambulatory BP measurement).
Disqualifiers
Known secondary cause of hypertension
Anatomy not eligible for renal denervation
Systolic heart failure (LVEF < 50%)
Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.
Trial design
Treatments tested in this trial
- Sham procedure and maintenance of heart failure medications
- Renal denervation and maintenance of heart failure medications
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xinjiang Medical University
Lead sponsor
First Affiliated Hospital of Xinjiang Medical University
Sponsor institution
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Source ClinicalTrials.gov