24/68 Management of blood pressure in elderly people with hypertension and symptomatic postural hypotension commissioning brief

Introduction

The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

What is the best strategy to manage blood pressure in elderly people with essential hypertension and symptomatic postural hypotension?

1. Patient group:
      - Have a past or current medical history of essential hypertension (applicants to define and justify blood pressure threshold for inclusion in trial, and method of measurement).
      - Presence of postural hypotension (applicants to define and justify definition and method of measurement).
      - Presence of symptoms attributable to postural hypotension on standing (e.g. lightheadedness, syncope, falls).
   Research should take into account the clinical heterogeneity of conditions associated with postural hypotension, and their underlying pathophysiological mechanisms when defining potential sub-groups.
   Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. 
2. Intervention: A strategy that prioritises control of hypertension – applicants to define and justify.
3. Comparator: A strategy that prioritises control of postural hypotension symptoms – applicants to define and justify.
4. Important outcomes: Improvement or worsening of symptoms of postural hypotension; Improvement or worsening of blood pressure control (applicants to define how this is measured).
   Other outcomes: Hospital admissions (injurious falls, syncope, cardiovascular events); Quality of life measures; Activities of daily living; Fidelity to strategies; Health economic measures (applicants are encouraged to explore appropriate approaches to health economic analysis for this patient group).  
   Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant).  
5. Setting: Primary and/or Secondary care; Applicants to justify choice.
6. Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial. Applicants are encouraged to work collaboratively and consider study designs that allow for comparison of different interventions and strategies. 
7. Minimum duration of follow-up: Applicants to define and justify, but should not be shorter than 12 months.
   Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow-up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Postural hypotension (PH), also known as orthostatic hypotension, is defined by a fall in blood pressure (BP) that occurs within three minutes of standing from a seated or lying position. This can cause dizziness or light headedness when standing up, blurred vision, weakness, nausea, difficulty concentrating and temporary loss of consciousness. PH occurs when the autonomic compensatory mechanisms that counteract the blood pooling effects of gravity when you stand up fail causing a drop in blood pressure.

PH is common in older people and can affect up to 30% of older people living in the community and 70% of older people living in long term care. PH is associated with a reduction in quality of life, is a common cause of falls and can result in increased hospital admissions and mortality. Figures from the NHS England Hospital Episode Statistics data demonstrate there was a 110% increase in admissions due to PH between 2008 and 2017. PH is implicated in approximately 25-50% of all falls and is associated with £0.5-1 billion of the £2 billion annual NHS cost of falls.

PH is a common comorbidity among patients with hypertension, with hypertension being present in approximately 70% of patients with severe PH. The treatment of patients that have both conditions remains a management challenge because treatment of one could worsen the other. In elderly patients that have both hypertension and PH, the intensity of anti-hypertensive is often reduced in an attempt to reduce symptoms such as falls. However current evidence, mainly from large hypertension trials suggest that this approach may be misguided. More research is required to guide the management of these complex patients and help reduce dizziness, falls and hospital admissions, and improve quality of life, while managing cardiovascular risk. The HTA programme therefore wishes to commission the trial outlined above.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you would like to apply for this call, you can begin your application via the funding call page.

Your application must be submitted online no later than 1pm on 27 November 2024. Applications will be considered by the HTA Funding Committee at its meeting in January 2025.

Guidance notes and supporting information for HTA Programme applications are available.

Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2025.

Applications received electronically after 1pm on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).

For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.

Should you have any queries please email htacommissioning@nihr.ac.uk.