Heart Failure
Conditions
Brief summary
Renal denervation can be carried out for heart failure
Detailed description
There are theoretical reasons why renal denervation might be beneficial for patients with chronic heart failure. It is not known whether they would suffer large drops in blood pressure which might compromise safety. This pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.
Interventions
DEVICERenal denervation
Renal denervation
Sponsors
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
-Patients were required to have chronic symptomatic systolic heart failure (NYHA class III or IV) on maximal tolerated medical therapy, including beta-blocker, ACE inhibitor or angiotensin receptor blocker, and spironolactone.
Exclusion criteria
* Clinically unstable patients or those with significant valvular disease * An estimated glomerular filtration rate \<35 ml/min * Unfavourable renal anatomy * Tortuous femoral arteries were not eligible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 6 months | Renal denervation had been reported to cause a 30 mmHg fall in blood pressure when used in hypertension. Although in principle renal denervation might be favourable for physiology in chronic heart failure, numerous theoretical possibilities exist for the procedure causing deterioration in clinical status, including the possibility of a large fall in blood pressure. A deterioration in symptomatic status or occurrence of an event such as presyncope or syncope would be considered a primary outcome event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 6 months | Monitored as inpatient for 5 days, then as outpatient for 6 months |
| Serum Creatinine | 6 months | — |
| Serum potassium | 6 months | — |
| 6 minute walk distance | 6 months | — |
| Serum sodium | 6 months | — |
Other
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction by Echocardiography | 6 months |
Outcome results
None listed