To investigate whether circadian rhythms in patients with chronic systolic heart failure are disturbed
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Circadian expression profile of clock (controlled) genes in the blood, e.g.
BMAL 1 (Brain and muscle aryl hydrocarbon receptor nuclear trans locator
(ARNT~}like protein -1, CRY1 (Cryptochrome protein 1 ), PER2 (Period circadian
protein homolog 2), PER3 (Period circadian protein homolog 3), REV-ERBa, DBP
(Albumin D-box binding protein).
Secondary outcome
Daytime sleepiness (Epworth Sleepiness Scale)
Chronotype (Chronotype questionnaire)
Medication (Medication record)
Food + coffee intake
24h blood pressure profile
24h activity profile (actometer)
24h cardiac electrical activity (ECG) profile
Background summary
Heart failure is one of the major chronic cardiovascular diseases. It is
associated with severely reduced quality of life and a poor prognosis.
Interestingly, neurohormones particularly relevant in heart failure, such as
glucocorticoids, catecholamines, growth hormone, atrial natriuretic factor,
angiotensin II, aldosterone, and renin, exhibit diurnal variation. While it has
been long known from clinical practice that patients with heart failure often
suffer from insomnia, reversely insomnia was also found to increase the risk of
incident heart failure in a prospective study. Strong links have been
established between circadian rhythms and renal function (often disturbed in
heart failure and vice versa), hypertension (a major contributor to heart
failure), and ischemia*reperfusion tolerance (as in myocardial infarction, also
a major contributor to heart failure) both in humans and in mice.
Study objective
To investigate whether circadian rhythms in patients with chronic systolic
heart failure are disturbed
Study design
Observational case-control study.
Study burden and risks
Hospitalized chronic systolic heart failure patients and control patients are
asked to participate in the following:
- Complete 2 short questionnaires about speepiness and sleeping behaviour
- Keep a diary of food- and fluidintake during 24 hours.
- Blood samples taken at 7 different timepoints (9:00, 13:00, 17:00, 21:00,
1:00, 5:00, and 9:00 hour)
a. PAX gene tubes to stabilize intracellular RNA in blood (2,5ml per timepoint)
b. 7 serum tubes (5ml per timepoint)
- 1 day ambulatory blood pressure measurement (after dismissal, no lifestyle
rules)
- 1 day ambulatory Holter monitor (after dismissal, no lifestyle rules)
- 4 days actometer (after dismissal, no lifestyle rules)
The risk and burden of the patients are minimal: all procedures are done during
an already planned admission to the hospital and around already planned visits
to the outpatient clinic, so patients don't have to come to the hospital
especially for the study. In addition, the burden of the measurements is low.
The questionnaires are short, there is an easy food- and fluids diary which has
to be filled in for only 24 hours, blood will be collected from an existing
hypodermic needle and the blood pressure monitor, Holter monitor, and actometer
will impede patients minimally in their activities.
There is no direct personal benefit for the participants in this study. The
collected data help to understand the circadian clock problems in heart failure
patients. In the future this can possibly be used to define therapeutic targets
or develop chronopharmacotherapy
Heidelberglaan 100
Utrecht 3584CM
NL
Heidelberglaan 100
Utrecht 3584CM
NL
Listed location countries
Age
Inclusion criteria
Patients: Patients (18-85 years) with chronic systolic heart failure NYHA II-III that have been admitted to the UMC Utrecht;Controls: Patients (18-85 years) that have been admitted to the hospital
Exclusion criteria
Patients:
-Blindness
-End stage renal failure (GFR < 15ml/min)
-Fever >38C
-CRP >20mg/L
-Use of hypnotics or other medication that disturbs the normal sleep pattern during study period
-Anaesthesia within 48 hours prior to start study
-Serious comorbidity that prevents participation according to the investigators (e.g. severe neurological, psychiatric, or oncologic diseases);Controls:
- Blindness
- Fever >38C
- CRP >20mg/L
- Use of hypnotics or other medication that disturbs the normal sleep pattern during study period
- Anesthesia within 48 hours prior to start study
- Serious comorbidity that prevents participation according to the investigators (including heart and kidney failure)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50383.041.14 |