Effects of Melatonin to Reduce Nocturnal Hypertension in Patients With Neurogenic Orthostatic Hypotension

• Status: Terminated
• Trial end date: 2019-05-28
• Target enrollment: 0
• Participant gender: All

Summary

Neurogenic Orthostatic Hypotension (NOH) is clinically defined as a consistent drop in systolic blood pressure (SBP) ≥30mmHg upon standing from a seated or lying position. However, 50% of NOH patients also have associated supine hypertension. It has been proposed that supine hypertension is the result of intact post-ganglionic sympathetic nerves and therefore due to residual sympathetic tone. Furthermore, research investigating the effects of melatonin shows blood pressure implication of this naturally secreted hormone. Specifically, melatonin has been investigated as a non-traditional anti-hypertensive agent for patients with essential and nocturnal hypertension. Central and peripheral mechanisms have been proposed to help explain how melatonin reduces blood pressures. Therefore, we aim to identify NOH patients as having either intact or denervated post-ganglionic sympathetic nerves, monitor the correlation to supine hypertension and subsequently investigate the effects of melatonin on blood pressure in these patients.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Melatonin; Yohimbine

Criteria

Inclusion Criteria:

• Control population: Healthy males or females between the ages of 18-80.

• Patient population: Males or females who have been previously diagnosed with Neurogenic Orthostatic Hypotension.

Exclusion Criteria:

Patient population:

1. Medical therapies or medications which could interfere with testing of autonomic function.

2. Clinically significant heart disease.

3. Presence of unrelated nerve damage in the peripheral nervous system.

4. Pregnant or breast feeding females.

5. The presence of failure of other organ systems or systemic illness that can affect autonomic function or your ability to cooperate. These include dementia, heart failure, kidney or liver disease, severe anemia, alcoholism, any new and abnormal cell growth identified as malignant, hypothyroidism, surgical procedures where the nerves of the sympathetic nervous system have been cut, or cerebrovascular disease.

Exclusion criteria for monitoring the effects of melatonin

1. All the above PLUS No lying/night time hypertension as determined by 24-hour blood pressure monitoring

Exclusion criteria for healthy controls:

1. Presence of ANY autonomic dysfunction

2. Medical therapies or medications which could interfere with testing of autonomic function.

3. Clinically significant heart disease.

4. Presence of ANY nerve damage in the peripheral nervous system.

5. Pregnant or breast feeding females.

6. The presence of failure of other organ systems or systemic illness that can affect autonomic function or your ability to cooperate. These include dementia, heart failure, kidney or liver disease, severe anemia, alcoholism, any new and abnormal cell growth identified as malignant, hypothyroidism, surgical procedures where the nerves of the sympathetic nervous system have been cut, or cerebrovascular disease.